Which ISO class is considered clean air for a sterile compounding area?

ISO Class 5 is recognized as the clean air standard for sterile compounding areas. This classification allows for a maximum allowable particle count of 3,520 particles per cubic meter for particles that are 0.5 micrometers or larger and is essential in maintaining the required aseptic environment for preparing sterile products. The low level of particulate matter in ISO Class 5 helps to minimize the risk of contamination during the compounding process, which is critical for ensuring patient safety when administering sterile medications.

In sterile compounding, achieving an environment that restricts microbial and particulate contamination is necessary. This is why compounding areas are often required to operate under conditions meeting or exceeding ISO Class 5. This allows for the safe handling and preparation of injections, infusions, and other sterile preparations, which may be detrimental if contaminated during compounding. Other ISO classes do not provide the same level of cleanliness as ISO Class 5, making them unsuitable for sterile compounding practices.